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Can E-cadherin Found in Tissue/Blood be Valuable in Identifying & Monitoring Patients With Post-proton Pump Inhibitor (PPI)-Responsive Heartburn

This study has been completed.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill Identifier:
First received: June 22, 2010
Last updated: December 16, 2016
Last verified: December 2016
The purpose of this research study is to determine in heartburn patients with nonerosive disease if detecting the presence of a fragment of the protein e-cadherin in esophageal epithelium or the amount of fragments of e-cadherin in blood can be used to monitor healing of esophagitis treated with a proton pump inhibitor (PPI). The hypothesis is that the presence of fragments of e-cadherin in esophageal epithelium or the amount of fragments of e-cadherin in blood can you useful as a biomarker for the healing of esophagitis in patients successfully treated with a PPI.

Condition Intervention Phase
Heartburn Gastroesophageal Reflux Disease Drug: Dexlansoprazole Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Can Detection of Fragments of Cleaved E-cadherin in Tissue and/or Blood be of Value for Identifying and Monitoring Patients With PPI-responsive Heartburn?

Resource links provided by NLM:

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Dexlansoprazole [ Time Frame: 4 weeks ]
    Primary outcome measure: To determine whether detection of cleaved fragments of e-cadherin in esophageal biopsies and in serum can discriminate between nonerosive patients with PPI-responsive and PPI-refractory heartburn.

Secondary Outcome Measures:
  • Dexlansoprazole [ Time Frame: 4 weeks ]
    To determine whether serum levels of N-terminal fragments of e-cadherin can be useful to monitor esophageal healing in patients with nonerosive PPI-responsive heartburn.

Enrollment: 40
Study Start Date: June 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexlansoprazole Drug: Dexlansoprazole
Dosage: 30 mg once per day for 4 weeks by mouth
Other Name: Kapidex

  Show Detailed Description


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: (all responses must be Yes)

  • Between 18 and 75 years of age
  • Male or non-pregnant, non-lactating female
  • Willing and able to undergo endoscopy with biopsies and a blood draw
  • Willing and able to discontinue use of PPIs for at least 1 month prior to the study start date
  • Endoscopy-negative heartburn of moderate severity at least 3 times-a-week for 3 months

Exclusion Criteria:(all responses must be No)

  • History of:

    • Barrett's Esophagus
    • Erosive Esophagus
    • Zollinger Ellison syndrome
    • bleeding disorder
    • upper gastrointestinal bleeding or malignancy
    • esophageal motor disorder
    • esophageal stricture
    • esophageal varices
  • Had the following surgeries:

    • organ transplant
    • gastric or esophageal surgery for the treatment of: Esophageal Cancer, Achalasia, Gastroesophageal Reflux Disease (GERD); i.e. Nissen Fundoplication
  • Have any of the following:

    • Current malabsorption
    • inflammatory bowel disease
    • severe heart-lung-liver or renal cerebrovascular disease
    • known hypersensitivity to PPIs
  • Currently taking any of the following medications:

    • Quinidine
    • quinine
    • benzodiazepines
    • antineoplastic agents
    • dilantin
    • warfarin
    • non-steroidal anti-inflammatory drugs
    • narcotics
    • prostaglandins
    • salicylates (except baby aspirin for cardiovascular protection)
    • H2-receptor antagonists
    • PPIs other than study agent
    • steroids
    • promotability drugs
    • sucralfate
    • KCl
    • anti-tuberculosis medication
    • oral biphosphonates
    • drugs requiring acid for absorption (iron, ampicillin, digoxin and ketoconazole)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01149395

United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Principal Investigator: Roy C Orlando, MD University of North Carolina, Chapel Hill
  More Information

Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01149395     History of Changes
Other Study ID Numbers: 10-0417
Study First Received: June 22, 2010
Last Updated: December 16, 2016

Keywords provided by University of North Carolina, Chapel Hill:
Gastroesophageal Reflux Disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents processed this record on September 19, 2017